# FDA recall Z-1167-2025

> **Exactech, Inc.** · Class II · device recall initiated 2024-12-31.

## Product

Alteon XLE    Item Number / Product Description:  140-22-70	NV EHXL NTL LNR G00 22MM  140-28-50	NV EHXLNTRL LNR G0 28MM  140-28-51	NV EHXLNTRL LNR G1 28MM  140-28-52	NV EHXL NTRL LNR G228MM  140-32-51	NV EHXL NTRL LNR G132MM  140-32-52	NV EHXL NTRL LNR G232MM  140-32-53	NV EHXL NTRL LNR G332MM  140-32-54	NV EHXLNTRL LNR G4 32MM  140-32-55	NV EHXLNTRL LNR G5 32MM  140-36-52	NV EHXLNTRL LNR G2 36MM  140-36-53	NV EHXL NTRL LNR G336MM  140-36-54	NV EHXLNTRL LNR G4 36MM  140-36-55	NV EHXLNTRL LNR G5 36MM  140-40-53	NV EHXLNTRL LNR G3 40MM  140-40-54	NV EHXLNTRL LNR G4 40MM  140-40-55	NV EHXLNTRL LNR G5 40MM  142-22-68	NV EHXL ALPLNR G00 22MM  142-22-70	NV EHXL LIPLNR G00 22MM  142-28-50	NV EHXL LIP LNR G0 28MM  142-28-51	NV EHXL LIP LNR G1 28MM  142-28-52	NV EHXL LIP LNR G2 28MM  142-28-60	NV EHXL ALIPLNR G0 28MM  142-28-61	NV EHXL ALIP LNR G1 28MM  142-28-62	NV EHXL ALIP LNR G2 28MM  142-32-51	NV EHXL LIP LNR G1 32MM  142-32-52	NV EHXL LIP LNR G2 32MM  142-32-53	NV EHXL LIP LNR G3 32MM  14

## Reason for recall

Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.

## Distribution

U.S.: AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MN, NV, NY, OH, OK, PR,SC, TN, TX and VA  O.U.S.: Argentina, Colombia, Germany, Guatemala, Japan and Spain

## Key facts

- **Recall number:** Z-1167-2025
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-31
- **Report date:** 2025-02-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gainesville, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1167-2025

## Citation

> AI Analytics. FDA recall Z-1167-2025. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-1167-2025. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*